Chronic Otitis MediaNCT04396145
The Effects of Chronic Otitis Surgery on SVV
An observational study of Chronic Otitis Media, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial summary
Inner ear trauma during chronic otitis surgery is one of the major concerns of Otolaryngology. Hearing thresholds or semicircular canals were investigated with this purpose. The investigator's aim is to test the utricle for surgical trauma. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Otitis Media
- What is being tested?
- Subjective Visual Vertical
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 29 Apr 2020to 30 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Adult, Older adult
Study population: Patients with chronic otitis media
Who may be able to join
- Chronic Otitis Media
- Who had surgical treatment
Who cannot join
- A patient who had the vestibular disease before
- Neurologic disease
- Patients who had ear, brain and musculoskeletal surgery before
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Chronic Otitis Surgery on Virtual Subjective Vertical
Inner ear trauma during chronic otitis surgery is one of the major concerns of Otolaryngology. Hearing thresholds or semicircular canals were investigated with this purpose. The investigator's aim is to test the utricle for surgical trauma.
Read the detailed description
All patients who will have surgery for ear will be tested before the operation and after the first day and the first week. Virtual SVV(Interacoustics) will be used for testing. The deviation angle from the vertical line will be measured when 15, 30, and 45-degree head tilt to the left and right side while they were standing.
- Conditions
- Chronic Otitis Media
- Being tested
- Subjective Visual Vertical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subjective Visual VerticalDiagnostic test
All subjects will have Virtual SVV before and after the operation
| Study group | Role | What they receive |
|---|---|---|
| Surgery group | Subjects who will have chronic otitis media surgery will be included in the study. Receives: Diagnostic Test: Subjective Visual Vertical |
What is being measured
The primary outcome is the main question the study is designed to answer.
SVV angle
Right and Left deviation angle when head tilted 15, 30, and 45 degree
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2020
- Study start29 Apr 2020
- Primary completion30 Dec 2028 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Otitis MediaStudies of the same condition, open and under way.
- More trials run by Pamukkale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fazıl Necdet Ardıç, Pamukkale University
- Investigators
- Fazıl N Ardıç, Principal investigator, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04396145
- Sponsor's protocol ID
- 5
- Status last verified
- Jul 2026
- First submitted
- 17 May 2020
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data will be available in university depository
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Chronic Otitis Surgery on Virtual Subjective Vertical
- ClinicalTrials.gov ID
- NCT04396145
- Acronym / sponsor ID
- 5
- Conditions
- Chronic Otitis Media
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 29 Apr 2020 (actual)
- Primary completion
- 30 Dec 2028 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 20 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Inner ear trauma during chronic otitis surgery is one of the major concerns of Otolaryngology. Hearing thresholds or semicircular canals were investigated with this purpose. The investigator's aim is to test the utricle for surgical trauma.
Detailed description
All patients who will have surgery for ear will be tested before the operation and after the first day and the first week. Virtual SVV(Interacoustics) will be used for testing. The deviation angle from the vertical line will be measured when 15, 30, and 45-degree head tilt to the left and right side while they were standing.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgery group | – | Diagnostic Test: Subjective Visual VerticalSubjects who will have chronic otitis media surgery will be included in the study. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic otitis media
Key inclusion criteria (2 listed)
- Chronic Otitis Media
- Who had surgical treatment
Key exclusion criteria (3 listed)
- A patient who had the vestibular disease before
- Neurologic disease
- Patients who had ear, brain and musculoskeletal surgery before
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Subjective Visual VerticalAll subjects will have Virtual SVV before and after the operation | Diagnostic test | Surgery group |
Primary outcome
SVV angle
Time frame: 1 week
Right and Left deviation angle when head tilted 15, 30, and 45 degree
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Individual participant dataSharing planned: No. The data will be available in university depository
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fazıl N Ardıç principal investigator
Pamukkale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Otitis Media, run by Pamukkale University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SVV angle (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026; AzTrials last refreshed its copy on 6 Nov 2026.